Senior Regulatory Specialist

FONG'S ENGINEERING AND MANUFACTURING PTE LTD

D17 Loyang, Changi, 79 LOYANG WAY 508766
Sgd 4,000 - 5,500 / monthly pm
On-site
Fda regulated industry
Knowledge & enablement
Quality control
FONG'S Engineering and Manufacturing Pte Ltd is seeking a Senior Regulatory Specialist to provide strategic regulatory guidance for medical device product development and compliance. The role involves preparing regulatory submissions, liaising with authorities, and ensuring adherence to evolving regulations for timely product launches

Job Summary

  • · Prepare,submit, and maintain premarket regulatory filings, including U
  • FDA 510(k) submissions,EU Technical Files /Design Dossiers for Class I, IIa, and III medical devices, andglobal medical device licensing submissions as applicable
  • · Liaisewith and coordinate submissions, registrations, variations, and renewals withglobal regulatory authorities to ensure continued market access

Matching Summary

Match Score: 85

FONG'S Engineering and Manufacturing Pte Ltd is seeking a Senior Regulatory Specialist to provide strategic regulatory guidance for medical device product development and compliance. The role involves preparing regulatory submissions, liaising with authorities, and ensuring adherence to evolving regulations for timely product launches.

Salary

SGD 4,000 - 5,500 / Monthly

Skills & Requirements

Must-have

  • FDA Regulated Industry
  • Knowledge & Enablement
  • Quality Control
  • Regulatory Strategy
  • Renewals

Nice-to-have

  • Stakeholder Engagement
  • Preparedness
  • Medical Devices
  • Vigilance
  • Management

Key Requirements

  • Minimum 4 years experience

Work Rights

Tailored Resume

Cover Letter